News Brief: FDA Issues Draft ICH Stability Guideline for Public Comment

The U.S. Food and Drug Administration (FDA) just published a draft guidance titled “Q1 Stability Testing of Drug Substances and Drug Products.” This guidance is a consolidated revision of several earlier stability guidelines (Q1A(R2), Q1B, Q1C, Q1D, Q1E and Q5C) by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which was adopted by ICH in April. It aims to provide a harmonized approach to stability testing for a wide range of drug products, including the following types not fully addressed in the earlier guidance:

• Advanced Therapy Medicinal Products (ATMPs)
• Vaccines
• Complex biologics

The FDA notes that the draft is available in the ICH guideline format but will be reformatted into the FDA guidance style for the final document.

The FDA is accepting public comments until August 25. For more information on the document and commenting, click here.